Kornimate/medical-research-clean huggingface dataset:
allogeneic immunotherapy of hematological malignancies using regulatory t-cell selective depletion

Conditions: Hematological Malignancies; Regulatory T Cell Depletion; Relapse

Summary: since the discovery that treg suppress anti-tumor immune responses, inhibiting their function has become a major challenge for the development of efficient immunotherapy for cancer. in humans, we previously reported the positive results of a first clinical trial using treg depletion for anti-tumor response amplification in the field of allogeneic hematopoietic stem cell transplantation (hsct). the present project aims at developing this anti-tumor immunotherapeutic strategy in the same setting, i.e. donor lymphocyte infusion (dli) for relapsing hematological malignancies after hsct, using a new selection marker: cd127. the choice of this new strategy is supported by our results of a retrospective clinical study and pre-clinical data. using human cells, this studies demonstrated, in vitro and in vivo in animal murine models, that treg depletion through cd127 positive selection is much more efficient to improve allogeneic immune responses of donor t-cells as compared to the previous strategy using the cd25 marker.


Eligibility criteria:
inclusion criteria: * adult patient (older than 18 years old without upper limit of age) diagnosed with leukemia, myelodysplasia, myeloproliferative disorder or lymphoproliferative disorder (cll, myeloma, lymphoma) * previous allogeneic hsct from a matched sibling, haplo-identical or unrelated donor (any type of conditioning regimen) * haematological relapse (molecular, cytogenetic or cytological) after hsct * patient refractory (no or partial response) to one or several previous standard unmanipulated dli * availability of cryopreserved lymphapheresis * no loss of chance by using of dli rather than more incisive anti-tumor agents according to investigator appreciation * written informed consent before any intervention necessary for the trial * affiliation to a social security regime * negative pregnancy test for women of childbearing age participating in the study * effective contraceptive methods for men / women in line with the current ctfg recommendations version 1.1 exclusion criteria: * acute grade ≥ ii or moderate/severe chronic gvhd at the time of inclusion * patient receiving immunosuppressive treatment for gvhd or any other reason * creatinine clearance\< 50 ml/min * serum aspartate aminotransferase (ast)/serum glutamic-oxaloacetic transaminase (sgot) or alanine transaminase (alt)/serum glutamate pyruvate transaminase (sgpt) \> 5.0 x upper limit of normal (uln) * serum total bilirubin \> 50µm (expect for unconjugated hyperbilirubinemia due to gilbert's disease) * performance status ecog\>1 * severe infection according to ctcae grading (grade\>2) * pregnant or lactating women * patient under tutorship, curatorship or legal protection * ongoing participation in another interventional research protocol within the same field of immune modulation (through cell therapy or not) * state medical aid

Keywords: dli regulatory t cells depletion hematological malignancies relapse
reducing test anxiety in high school students

Conditions: Test Anxiety

Summary: school-age test anxiety is an important risk factor for school performance. notwithstanding, few studies seek to identify which strategies are effective in improving test anxiety. this study aimed to test whether a cognitive-behavioural intervention for high school students could significantly reduce test anxiety. a two-arm, cluster-randomized controlled, unblinded, parallel, trial was conducted. participants were students of the 10th year of the alves martins high school in viseu, portugal. students were randomized at class level to receive a cognitive-behavioural-based intervention combined with mindfulness, psychoeducation, and relaxation techniques, or to a control group with no intervention. participants' anxiety levels were measured using the test anxiety questionnaire. the analysis of the effect of the intervention was carried out on an intention-to-treat basis at the class level, using multilevel mixed effects models and bayesian modelling.


Eligibility criteria:
inclusion criteria: * 10th grade students; both students and parents provide written informed consent exclusion criteria: * cognitive inability to answer the questionnaire and/or to participate in the intervention
avert™ clinical trial for contrast media volume reduction and incidence of cin

Conditions: Contrast Induced Nephropathy (CIN)

Summary: the osprey medical avert system is indicated to reduce contrast media (cm) exposure to the kidneys during percutaneous coronary procedures thereby reducing the risk of contrast induced nephropathy (cin).

the purpose of this trial is to assess the avert system device, which is designed to limit the volume of cm (contrast media) utilized, during a staged therapeutic coronary pci (percutaneous coronary intervention) or a coronary diagnostic procedure that is anticipated to become a pci (i.e. ad hoc pci) for the reduction of cin (contrast induced nephropathy).

Eligibility criteria:
inclusion criteria: * the subject is a candidate for a therapeutic percutaneous coronary intervention (pci) procedure. * the subject has documented chronic kidney disease (ckd) exclusion criteria: * subject is in acute renal failure * assessment of ventricular function that cannot be accomplished without the use of the cm. * subject has acute stemi within 72 hours prior to planned pci procedure, or is currently having an acute stemi. * subject is unable to undergo peri-procedural hydration.
serum immunologic markers levels in during the delivery

Conditions: Immunologic Markers

Summary: this study aim to describe dynamics of immunologic markers c1 inhibitor, c3, c4 during the delivery in order to improve early diagnostics of obstetric emergencies, especially with immune etiology.

our prospective observational study will explore the differences between dynamics of the complement components c1 inhibitor, c1 inhibitor activity, c3, c4 during the labour in a group of women with physiologic pregnancy and in a group with a risk of complications (pre-eclampsia, hellp syndrome, placenta praevia, placental abruption, iugr, previous post partum hypotony). we will focus on women undergoing the caesarean delivery. we will also measure d vitamin levels and ace levels and search for some contexts.

Eligibility criteria:
inclusion criteria: * pregnant women undergoing the caesarean delivery * signed informed consent exclusion criteria: * previous hepatitis or other hepatocyte damage
evaluation of the influence of the virtual reality helmet on pain during iud insertion

Conditions: IUD

Summary: given the current lack of satisfactory options for the management of iud insertion pain, could the virtual reality headset be an innovative and effective tool? the objective is to compare the pain experienced during iud insertion between a group of women wearing a virtual reality helmet and a group not wearing one. observational, prospective, randomized, open-label, monocentric study.


Eligibility criteria:
inclusion criteria: * female adult * who has benefited from contraceptive counseling * the choice of an iud (hormonal or copper) * having signed a written informed consent. * affiliation to a social security scheme. exclusion criteria: * pre-existing dizzying sensations * severe facial wounds * history of epilepsy * persons of full age subject to legal protection (safeguard of justice, curatorship, guardianship), persons deprived of liberty.
a trial of high intensity versus low intensity neoadjuvant chemoradiotherapy in locally advanced rectal cancer

Conditions: Rectal Cancer

Summary: neoadjuvant chemoradiotherapy (crt) has been the standard therapy for local advanced rectal cancer. pathological complete response (pcr) is an important prognostic factor for local control and survival. a high intensity crt increases not only the pcr rate, but also toxicity, especially diarrhea. compared with traditional rt technique, intensity-modified radiation therapy (imrt) can decrease the toxicity of diarrhea because of low volume of high dose for small bowel. therefore, imrt technique provides an opportunity to improve the dose intensity of neoadjuvant crt. the investigators hypothesize that a higher treatment dose induces a high rate of pcr and design a two-arm trial. in this trial, low intensity crt includes the whole pelvic irradiation of 50gy together with oxaliplatin and capecitabine weekly. while in high intensity group, additional concomitant 5gy for primary tumor and a cycle of xelox are prescribed. all patients will receive a total mesorectal excision (tme) 8 weeks after crt.


Eligibility criteria:
inclusion criteria: * patients with rectal adenocarcinoma * clinical staged t3/4 or any node-positive disease * age: 18-75 years * karnofsky performance status \> 80 * adequate bone marrow reserve, renal and hepatic functions * without previous antitumoural chemotherapy * no evidence of metastatic disease * written informed consent before randomization exclusion criteria: * previous pelvis radiotherapy. * previous antitumoural chemotherapy * clinically significant internal disease

Keywords: neoadjuvant chemotherapy locally advanced rectal cancer intensity-modulated radiation therapy pathological complete response
chaplain-delivered compassion meditation to improve spiritual care of patients receiving stem cell transplantation

Conditions: Lymphoma; Multiple Myeloma

Summary: this clinical trial tests the feasibility, implementation and acceptability of chaplain delivered compassion meditation in order to improve spiritual care for patients receiving stem cell transplantation. hospital chaplains play a vital role in delivering emotional and spiritual care to a broad range of both religious and non-religious patients for a wide variety of stressors, and extensive research indicates that spiritual consults impact patient outcomes and satisfaction. compassion meditation is a secularized, research-based mindfulness and compassion meditation program designed to expand and strengthen compassion for self and others. practices include training in attentional stability and increased emotional awareness, as well as targeted reflections to appreciate one's relationship with self and others. by centering the mind, controlling debilitating ruminative thoughts, and cultivating personal resiliency and an inclusive and more accurate understanding of others. engaging in chaplain delivered compassion meditation may improve the spiritual care for patients receiving stem cell transplantation.

primary objective: i. to examine the feasibility, adoption, extent of implementation, acceptability and fidelity of chaplain-delivered compassion-centered spiritual health (ccsh). outline: patients are randomized to 1 of 2 arms. arm i: patients receive chaplain-led compassionate centered spiritual health sessions over 30 minutes, twice per week for up to 2 weeks. arm ii: patients receive a traditional chaplain consultation and care upon request, per standard of care. after completion of study treatment, patients are followed up at 80-100 days and 6 months post treatment.

Eligibility criteria:
inclusion criteria: * patient: within 6 weeks of scheduled hematopoietic stem cell transplant (hsct) * patient: \> 18 years of age * patient: speak and read english * chaplain: emory healthcare chaplain exclusion criteria: * patient: patients will be excluded if they are cognitively impaired, on a ventilator, or are in a room requiring enteric precautions or airborne precautions (e.g., use of an n-95 mask requiring fit-testing) to enter * chaplain: there will be no exclusion criteria and no consequence to the chaplains for refusing to volunteer
effect of whey protein' supplementation and exercise in patients with heart failure

Conditions: Heart Failure; Sarcopenia; Muscle Loss; Quality of Life

Summary: the aim of this study is evaluate the effect of whey protein supplementation on muscle mass preservation, improvement of strength and quality of life, and inflammatory parameters in patients with heart failure nyha i or ii followed by a cardiac rehabilitation program.

heart failure is the final route of most heart diseases and is a worldwide problem due to its high prevalence, morbidity and mortality. in brazil, it is an important cause of hospitalization and one of the most important health challenges, since its prevalence tends to increase with the aging of the population and the increase in the survival of patients who have suffered acute coronary events. this is an ongoing epidemic problem, resulting in a high socioeconomic cost, represented by the expense of medications, repeated hospitalizations, loss of productivity, early retirements, possible surgeries and, ultimately, heart transplantation. in this sense, it is of great importance to carry out studies that evaluate the possible benefits of new clinical and nutritional interventions for hf patients, favoring the development of treatment strategies for these individuals and also for public health. our hypothesis is based on the fact that whey protein supplementation associated with physical exercise in patients with heart failure could promote preservation of muscle mass, increase in muscle strength, and improve quality of life, body composition and physical capacity. the volunteers will receive 30 grams per day of whey protein or maltodextrin in a double-blind, controlled clinical trial lasting 12 weeks. during this period they will perform supervised physical exercise 3 times a week in a cardiac rehabilitation program. they will also receive nutritional counseling.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of heart failure nyha i or ii after medical evaluation; * indication to participate in a cardiac rehabilitation program; * fully medicated for heart disease; * age greater than or equal to 50 years; * ejection fraction less than 50%. exclusion criteria: * neoplasia at any site; * impaired renal function (\<50ml / min / 1.73m2); * impaired hepatic function (tgp\> 150u / l) or decompensated hepatic cirrhosis classified with child-pugh b or c; * presence of ressincronizer or other device; * atrial fibrilation; * allergy of milk protein.

Keywords: heart failure cardiac reabilitation nutritional status quality of life milk protein
practical application of indocyanine green camera in laparoscopic liver surgery

Conditions: Liver Tumor

Summary: "indocyanine green (icg) is a dye used as an indicator of hepatic function considering its capacity to be eliminated only by the bile. thus, icg tend to remain in liver tumors. the hypothesis of camvic study is that the use of fluorescence imaging during laparoscopic hepatic surgery will allow to detect small subcapsular superficial lesions undetected by other diagnostic methods, which will improve the results of the oncologic treatment."

"thanks to the property of icg to release a fluorescent signal when excited by a near infra red (nir) light source, icg fluorescence has been widely used during several clinical situations (angiography, lymphography,..). few years ago it has been shown that hepatic tumors could be seen with a nir camera able to view icg fluorescence thanks to the depot in or around the tumor of the dye injected during preop.since, this fluorescence imaging technique potential has been underlined to identify tumors undiagnosed before surgery. pre-operative examination of hepatic lesions is based on 3 points: * visual examination * two-hand palpation * intra-operative ultrasound. during laparoscopic hepatic surgery it is not possible to palpate the liver thus peroperative examination of the liver surface is harder than during open surgery. moreover per-operative ultrasound is not a reliable tool in order to explore liver surface. however the latest development of nir cameras able to view icg fluorescence could add a benefit in laparoscopic surgery in view of its capacity to detect superficial lesions, even those of small dimension."

Eligibility criteria:
inclusion criteria: * men and woman aged of 18 yo and more * patients with liver tumor * patient affiliated to french social security exclusion criteria: * patient unable to give a signed informed consent * patient under guardianship or curator * patient deprived of liberty by judicial or administrative decision or placed under judicial protection * patient refusing to undergo the specific technique * pregnant or lactating women * patient with icteric cholestasis * patient with contraindication to coelioscopy * patient with known allergy to cyanines * patient who must undergo staged hepatectomy

Keywords: hepatic tumor liver icg icg camera laparoscopy
sacubitril/valsartan for ckd5 stage dialysis patients

Conditions: CKD5 Stage Dialysis; Heart Failure

Summary: hemodialysis or peritoneal dialysis ckd5 patients were randomly divided into sacubitril/valsartan and irbesartan treatment groups. comparing the blood pressure, survival rates, the cardiac function, renal function,and adverse reactions of two groups, to evaluate whether the efficacy and safety of sacubitril/valsartan in the treatment of patients with ckd dialysis combined with heart failure is superior to that of irbesartan.


Eligibility criteria:
inclusion criteria: * ckd stage 5, starting regular hemodialysis or peritoneal dialysis for more than 1 month. * nt-probnp ≥2000pg/ml. * hypertension * voluntary informed consent. exclusion criteria: * unable to tolerate acei/arb class antihypertensive drugs; * history of symptomatic hypotension/systolic blood pressure \<100mmhg at screening; * potassium \>6.0mmol/l; * history of angioedema; * abnormal liver function such as alt and/or ast \>=3 times normal upper limit (uln), total bilirubin \>= 2 times uln; * moderate to severe anemia (hemoglobin \<80g/l); * cardiac surgery/intervention/cardiac resynchronization therapy has been performed in the past 3 months or is planned in the next 12 months; * newly found malignant tumor (within 3 years), or undergoing radiotherapy/chemotherapy; * pregnant and lactating women, or those of childbearing age who are unable to guarantee effective contraception; * new and serious life-threatening infections; * active infectious diseases such as active tuberculosis, active viral hepatitis and hiv infection; * persons suffering from mental disorders and taking psychotropic drugs; * patients with life expectancy less than 12 months; * the doctor assessed that the patient was not easy to follow up or had poor compliance and was not suitable for enrollment; * patients who do not want to sign informed consent.
cardiac resynchronisation therapy in combination with overdrive pacing in the treatment of central sleep apnea in chf

Conditions: Heart Failure; Central Sleep Apnea

Summary: the primary objective of this study is to compare the apnea- hypopnea index in hf patients with concomitant csa, after 12 weeks of crt alone to crt in combination with one night of overdrive pacing. secondary objectives are to evaluate the effects of a single night of overdrive pacing applied after 12 weeks of crt vs. crt alone on breathing events, sleeping events, and neurohormonal markers. an additional secondary objective of the study is to compare the efficacy of crt in hf patients with concomitant csa to hf patients without concomitant csa.

sleep apnea is a common and often undiagnosed disorder associated with substantial cardiovascular morbidity and mortality. in recent years studies have been published presenting the relationship between heart failure (hf) and central sleep apnea (csa). csa associated with cheyne-stokes respiration is a form of periodic breathing in which central apneas and hypopnea alternate with periods of hyperventilation, characterized by a regular crescendo-decrescendo oscillation of tidal volume, which is thought to be caused by dysfunction of central respiratory control. unlike, obstructive sleep apnea (osa), csa likely arises as a consequence of hf.since 2002, several results have reported on the benefit of atrial overdrive (aop) pacing in patients suffering from sleep apnea. these results could not be confirmed for obstructive sleep apnea in several subsequent studies. cardiac resynchronization therapy (crt) has been proposed as another potential therapeutic pacing approach for csa by two recently published investigations.the combined therapeutic impact of aop and crt (crt+aop) so far has not been investigated.we aimed to evaluate the effect of crt alone and crt+aop on csa in patients with chf.

Eligibility criteria:
inclusion criteria: * patients with documented clinical history of symptomatic but stable congestive heart failure, nyha iii or nyha iv, of at least six weeks duration. * patient has an indication for a crt device, or patients with previous pacemaker indication, except sick sinus syndrome, and currently in need for an upgrade to a crt device * patient is scheduled for the implantation of a crt device * patient is over 18 years of age * patient provides informed consent exclusion criteria: * inability to complete overnight sleep study as specified by the protocol * myocardial infarction or coronary revascularization procedure within 2 calendar months prior to enrollment * planned or strong likelihood of cardiac surgery within 4 months following enrollment * a spirometric confirmation of obstructive lung disease * evidence of obstructive sleep apnea at baseline polysomnography * body mass index \>30 kg/m² * pregnant women

Keywords: sleep apnea, crt
does immunotherapy have a role in the management of endometriosis?

Conditions: Endometriosis

Summary: pathological specimens of 40 women that had been operated for endometriosis will be included in this study. these tissues will be stained with a marker named as pdl-1 in pathological examination. "programmed cell death (pd-1)" is expressed on t cells. the immunotherapies in which antibodies against these pd-1 and its ligands (pdl-1) have been used are accepted as very effective in the treatment of many cancers. if these ligands can be shown in the endometriosis, it will be an important step for the treatment of endometriosis.

40 women who had been operated for endometriosis between 2013 and 2014 will be included in this study. pathological specimens will be stained with an immunohistochemical marker named as pdl-1. "programmed cell death (pd-1)" is a protein containing 288 aminoacids and expressed on t cells. it was shown on apoptotic cells in earlier times, but then it has been understood that its physiologic role is not cell death. the upregulation of pd-1 is a result of the activation of t cells and it is necessary for the termination of immune response. pd-l1 is a ligand for pd-1. the immunotherapies in which antibodies against these pd-1 and its ligands (especially pdl-1) provides significant improvements in many cancers such as melanoma. evidence about the role of these ligands in endometriosis will be an important step in its management.

Eligibility criteria:
inclusion criteria: * patients operated for endometriosis between 2013 and 2014 * pathological examinations proving the diagnosis of endometriosis exclusion criteria: * patients operated for cysts other than endometriosis